Effect of Vibro-tactile Stimulation Intensity on Head Posture in Cervical Dystonia

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
University of Minnesota
Study ID
NCT07245615
Status
Recruiting
Apply to this trial

Conditions

  • Cervical Dystonia

Eligibility Criteria

Sex
ALL
Age
30 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • cervical vibrotactile stimulation — DEVICE
    The intervention in this study is vibrotactile stimulation with 3 different intensities on 4 combinations of cervical muscles. The three intensity levels are 0.25mm, 0.64mm, and 1.48mm of movement range of the vibrator, when attached to the cervical area. The four muscle combinations (left and right SCM, left and right TRP, left SCM and TRP, right SCM and TRP) are selected as they were shown to be more effective than other combinations in a previous studies. The total number of bouts of stimulation is 12 (3 intensities \* 4 muscle combinations). Each VTS application is 2 minutes long, resulting in total stimulation time of 24 minutes. There will be a 5-minute break of no-vibration between each application of vibration. During the intervention, the participant will remain seated and asked to not interfere voluntarily with dystonic muscle spasms. During breaks, they can adjust their head posture for their comfort. Extra breaks will be given if needed.

Study Details

The primary goal of this clinical trial is to examine the effects of cervical vibrotactile stimulation intensity on abnormal head posture in people with cervical dystonia. The main question is: Does higher vibration intensity correct head posture to a greater extent than lower vibration intensity? Researchers will compare the head posture of participants with cervical dystonia who receive different intensities of vibration to cervical muscles. The secondary goal of this clinical trial is to examine the degree of proprioceptive impairment in cervical dystonia. Specifically, the study will assess proprioceptive impairment at the neck, wrist, and ankle joints, and seeks to determine whether the impairment improves with cervical vibrotactile stimulation. Researchers will compare the proprioception testing results of these joints between cervical dystonia patients and age- and sex- matched healthy controls. Researchers will also compare the neck proprioception testing results of cervical dystonia patients before and after stimulation. Participants will visit the lab once for three hours, where they will go through: 1. clinical questionnaires; 2. neck, wrist, and ankle proprioception testing, 3. vibrotactile stimulation where they sit and relax 4. neck proprioception testing

Key Dates

Start date
Mar 10, 2025
Status verified
Jun 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cervical Dystonia Group
    All participants with cervical dystonia will be in this group to receive the intervention. After answer three questionnaires (The Mini Mental State Examination, the Revised Toronto Western Spasmodic Torticollis Rating Scale and Psychiatric Screening Tool, Fahn, Tolosa, Marin Tremor Rating Scale), their neck, wrist, and ankle proprioception will be tested respectively. They they will go through the intervention of cervical vibrotactile stimulation. Lastly, their neck proprioception will be tested again.
  • No Intervention: Healthy Controls
    Healthy people age- and sex- matched with participants with cervical dystonia will be in this group. This group will only be tested on their neck, wrist, and ankle proprioception, to compare with the cervical dystonia group.

Primary Outcome Measure

Head Angle Index [ Time Frame: As part of the one-time visit, this part will take 90 minutes. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Human Sensorimotor Control LaboratoryMinneapolisMinnesota55455-

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Human Sensorimotor Control Laboratory· Minneapolis, MN

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